Sanofi Hemophilia Drug Gets Breakthrough Designation From FDA

Sanofi said its experimental hemophilia drug got breakthrough therapy designation from the U.S. Food and Drug Administration, which could speed up its approval process.

Efanesoctocog alfa is the first factor VIII therapy to be awarded such status, the French drugmaker said Wednesday. The FDA gave the designation based on successful data from a third-phase clinical trial.

Hemophilia A is a rare and life-threatening bleeding disorder that occurs in about one out of every 5,000 male births, and more rarely in females. Breakthrough therapy designation is intended to expedite the regulatory process for drugs that target serious or life-threatening conditions.

Sanofi ...